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Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02071823
Recruitment Status : Completed
First Posted : February 26, 2014
Results First Posted : January 9, 2015
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson
Intervention Drug: BIA 9-1067
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Fed/Fasted Group B Fasted/Fed
Hide Arm/Group Description

A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fed Washout Period (7days) Period 2: Fasted

BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.

A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fasted Washout Period (7days) Period 2: Fed

BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.

Period Title: Overall Study
Started 6 6
Completed 5 6
Not Completed 1 0
Arm/Group Title Group A Fed/Fasted Group B Fasted/Fed Total
Hide Arm/Group Description

A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fed Washout Period (7days) Period 2: Fasted

BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.

A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fasted Washout Period (7days) Period 2: Fed

BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.

Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
12
 100.0%
1.Primary Outcome
Title Cmax - Maximum Observed Plasma Concentration
Hide Description Cmax - Maximum observed plasma concentration of BIA 9-1067
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fasted Conditions Fed Condition
Hide Arm/Group Description:
Fasted conditions period
Fed condition period
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
635.0  (250.8) 238.2  (168.4)
2.Primary Outcome
Title AUCt - Cumulative Area Under the Plasma Concentration Time Curve
Hide Description AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fed Conditions Fasted Condition
Hide Arm/Group Description:
Fed conditions period
Fasted condition period
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: ng·h/mL
879.2  (286.6) 1989.5  (984.8)
3.Primary Outcome
Title Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)
Hide Description Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fasted Conditions Fed Condition
Hide Arm/Group Description:
Fasted conditions period
Fed condition period
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: ng·h/mL
2113.6  (915.2) 1027.2  (545.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fasted Conditions Fed Condition
Hide Arm/Group Description Fasted conditions period Fed condition period
All-Cause Mortality
Fasted Conditions Fed Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Fasted Conditions Fed Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fasted Conditions Fed Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   3/11 (27.27%)   4/12 (33.33%) 
Blood and lymphatic system disorders     
Anaemia  0/11 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal stiffness  1/11 (9.09%)  0/12 (0.00%) 
Nervous system disorders     
Somnolence  2/11 (18.18%)  4/12 (33.33%) 
Disturbance in attention  0/11 (0.00%)  1/12 (8.33%) 
Headache  1/11 (9.09%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasopharyngitis  0/11 (0.00%)  1/12 (8.33%) 
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Research
Organization: Bial – Portela & Cª, S.A.
Phone: +351 229 866 100
EMail: jose.rocha@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02071823    
Other Study ID Numbers: BIA-91067-104
First Submitted: January 19, 2012
First Posted: February 26, 2014
Results First Submitted: December 31, 2014
Results First Posted: January 9, 2015
Last Update Posted: January 9, 2015